← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K121237

# BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE (K121237)

_Cliniqa Corporation · JJX · May 18, 2012 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K121237

## Device Facts

- **Applicant:** Cliniqa Corporation
- **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md)
- **Decision Date:** May 18, 2012
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1660
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Indications for Use

Cliniqa Beta HCG Control Level 1, Cliniqa Beta HCG Control Level 2, Cliniqa Beta HCG Control Level 3, are assayed quality control materials used to monitor the precision of Beta HCG assays. Cliniga Beta HCG Calibration Verification Controls, Levels 1, 2, and 3 are assayed quality control materials used to monitor the precision of Beta HCG assays.

## Device Story

Assayed quality control materials; human serum-based with purified human antigens, stabilizers, and preservatives. Used to monitor precision of Beta HCG assays. Ready-to-use liquid form; no reconstitution or freezing required. Used by laboratory personnel to verify assay performance; provides mean and expected range for specific lots. Stability: 3 years shelf life at 2-8°C; 30-day open-vial stability at 2-8°C. Benefits patient by ensuring accuracy and reliability of clinical Beta HCG test results.

## Clinical Evidence

No clinical data. Evidence consists of bench testing, including value assignment studies and real-time/accelerated stability testing to support shelf-life and open-vial claims.

## Technological Characteristics

Liquid quality control material; human serum matrix with added buffers, stabilizers, and purified human hormones. Storage at 2-8°C. Value assignment derived from representative lot analysis using reagents and calibrators standardized against NIBSC 75/589.

## Regulatory Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

## Submission Summary (Full Text)

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# Decision Summary

Statement for the Record, k121237

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K121237](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K121237)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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